Laboratory Animal Technology Lecture Quiz 1 - Laws and Regulations, and The Laboratory Animal Facility

Vivisection

The practice of operating on live animals for the purpose of experimentation or scientific research

• Diagnosis

• Treatment

• Prevention of diseases

• Animals used in research, teaching, and testing

What does laboratory animal medicine encompass?

• Disease detection

• Colony health monitoring programs

• Treatment of ill animals

• Blood sampling

• Tissue collection

Identify the ways in which a veterinary technician provides technical support to veterinarians in laboratory animal medicine

Institutional Animal Care and Use Committee (IACUC)

The institutional body with responsibility for review and oversight of the institution's program for the humane care and use of animals

Supports, facilitates, and promotes ethical and humane use of animals by upholding the standards set forth in policies, regulations, and guidelines

What is the responsibility of the Institutional Animal Care and Use Committee (IACUC)?

• No fewer than five members

• A veterinarian certified in laboratory animal medicine

• At least one scientist experienced with animal research

• A least one member of the public to represent community interests in the proper care and use of animals

• A least one non-scientist member

According to PHS policy, how many members must an IACUC board include?

• Reduce study duplication

• Reduce animal discomfort

• Justify species/number selection

• Assure veterinary care

• Enforce ethical guidelines

• Membership, meetings, and subcommittees

• Semiannual inspections and program reviews

• Suspension

Identify five responsibilities of an IACUC board

Twice a year

How often does IACUC inspect laboratory facilities?

Reduce, refine, and replace

Identify the Three R's involving the ethical use of animals in research proposed by Russell and Burch

• Use of models without animals including

• In-vitro methods

• Computer-based simulators

• Monoclonal grown in flasks instead of mice

• Artificial skin cultures

Identify ways in which the "replacement" principal of the Three R's is practiced

• Procedures to lessen pain and discomfort

• Replacement of tissue culture bottles instead of mice for monoclonal antibodies

• Vascular access port

• Osmotic pump

Identify ways in which the "refinement" principal of the Three R's is practiced

• Reduce the number of animals used for testing

• Use animal as it's own control

• Statistical analysis

• Same animal for more than one study (necropsy)

• 3 animals used instead of 12

Identify ways in which the "reduction" principal of the Three R's is practiced

American Association for Laboratory Animal Science (AALAS)

Nonprofit organization with a mission to advance responsible laboratory animal care and use to benefit people and animals

Laboratory Animal Management Association (LAMA)

Organization with a mission of enhancing the quality of management and care of laboratory animals by promoting education and professional development

American Society of Laboratory Animal Practitioners (ASLAP)

*Founded partially due to the 1966 Laboratory Animal Welfare Act

A professional organization through which veterinarians can exchange ideas, experiences, and knowledge related to laboratory animal medicine

American College of Laboratory Animal Medicine (ACLAM)

Specialty board recognized by the AVMA that encourages education, training, and research

National Association for Biomedical Research (NABR)

A nonprofit organization that advocates for sound public policy in support of ethical and essential animal use in biomedical research

National Association for Biomedical Research (NABR)

Serves as a unified voice in Washington, DC, for the scientific community on legislative and regulatory matters affecting laboratory animal research

Foundation for Biomedical Research (FBR)

A nonprofit organization dedicated to improving the quality of human and animal health by promoting public understanding and support for the humane and responsible use of animals in research

Institute for Laboratory Animal Research (ILAR)

Functions as an advisor to the federal government, biomedical research community, educators, students, and the public by developing resources for research, testing, and education

Institute for Laboratory Animal Research (ILAR)

Which organize developed the Guide for the Care and Use of Laboratory Animals?

USDA

Which organization only requires three IACUC members on their board?

Unannounced inspections at least annually

How often does the USDA inspect animal laboratory facilities?

• Caging, feeding, temperature, and humidity must be regulated

• Dogs must have exercise programs and all rodents and non-human primates must have an enrichment program

• Each facility must establish an IACUC board

• Anesthesia and analgesia must be given for painful procedures

• Personnel using animals must be properly trained

Identify examples of laboratory animal care and use regulations

• United States Department of Agriculture (USDA)

• Office of Laboratory Animal Welfare (OLAW)

• Institutional Care and Use Committee (IACUC)

• Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC)

• New York State Department of Health

• Good Laboratory Practices (GLPs)

• FDA

Identify the organizations that regulate animal use in research

• Animal Welfare Act

• USDA Regulations

• PHS Policy

• Guide for the Care and Use of Laboratory Animals

• AVMA Panel on Euthanasia

• Good Laboratory Practices (GLPs)

Identify the animal welfare regulation policies followed in laboratory animal medicine

AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care)

A private, nonprofit organization that promotes the humane treatment of animals in science by encouraging high standards of animal care, use, and well-being through voluntary accreditation and assessment programs

Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC)

Institutions that meet and exceed regulatory requirements may elect to pursue accreditation by an independent entity

Every three years

How often does AAALAC inspected laboratory animal facilities?

The Animal Welfare Regulations (AWR)

Describes what a facility must do to comply with the Animal Welfare Act

• Animal research facilities

• Animal dealers and exhibitors

• Operators of animal auction sales

• Carriers and transporters of animals

• Pet stores are exempt

Who do the Animal Welfare Act (AWA) regulations apply to?

• Feeding and watering

• Sanitation

• Lighting and ventilation

• Shelter from extremes of weather

• Separation of species

• Adequate veterinary care

Identify some of the standards regulated under the Animal Welfare Act (AWA)?

• Dogs and cats

• Non-human primates

• Guinea pigs and hamsters

• Rabbits

• Other warm-blooded animals designated by the Secretary of Agriculture

Which species are regulated under the AWA?

• Birds

• Mice, and rats specifically bred for research, teaching, or testing

• Horses not used for research purposes

• Farm animals intended for use in improving animal nutrition, breeding, food quality, etc.

Which species are NOT covered under the AWA?

1. Definition of Terms

2. Regulations

3. Standards

4. Rules of Practice

The Animal Welfare Regulations (AWR) is divided into four parts which are

USDA

Who regulates the Animal Welfare Act and Regulations?

At least 3 members

Per the Animal Welfare Act and Regulations, an IACUC board must consist of

Public Health Service (PHS) Policy

Requires institutions using warm-blooded animals in research funded by NIH to provide an assurance that the maintenance and treatment of animals be performed in accordance with the AWA and the Guide

OLAW (Office of Laboratory Animal Welfare)

Governmental body responsible for interpreting and implementing the PHS Policy and evaluating institutional compliance with it

AAALAC accredited

OLAW will waive site visits to laboratory animal facilities that are

All live vertebrate animals

Which species does PHS policy apply to?

Warm-blooded vertebrate animals excluding birds, rats, and mice bred for research

Which species does the Animal Welfare Act and Regulations apply to?

Must file an approved Animal Welfare Assurance, signed by the institutional official with OLAW

If a scientist is applying for a research grant involving the use of animals, what document must be submitted to IACUC?

USDA regulations and the PHS Policy

The Guide for the Care and Use of Laboratory Animals clarifies that programs should function in accordance with the

The outcome of programs and procedures rather than the means of achieving that outcome

The Guide employs performance-oriented standards meaning it measures success based on

AVMA Guidelines for Euthanasia

The Guide states that, unless justified for scientific or medical reasons, the method of euthanasia should be consistent with the most recent

Guide for the Care and Use of Agricultural Animals (Ag Guide)

Intended to supplement applicable federal and state laws, regulations, and policies and the Guide as they pertain to the use of agricultural animals

Ag Guide

Both the USDA and AAALAC follow the _____ when inspecting agricultural animals used in biomedical research

Good Laboratory Practice Regulations (GLP)

Sets framework for performing performing high-quality, well-documented, and repeatable safety studies

The nature of the research and testing activities

The design of an animal facility is determined largely by

Whistleblower policy (report concerns to boss, veterinarian, IACUC chair, institution official, etc.)

Intended to provide a framework for reporting suspected animal abuse

Animal Welfare Regulations (AWR) and Guide for Care and Use of Laboratory Animals

Space requirements for laboratory designs are specified in the

Disease protection

Laboratory design must consider relevant factors such as space requirements, legal requirements, traffic flow, specialist advice, etc.

What will these considerations contribute to?

The microbiological status of the animals, potentially jeopardizing the research studies in progress

The circulation patterns of people, animals, and equipment through a facility may have a major impact on

Controlling circulation

The layout of facility corridors is critical to

Single-corridor floor plan (most common design)

Which type of facility design has the highest risk for cross-contamination among animal rooms?

Dual-corridor floor plan

Facility design that reduces potential for cross- contamination with a one-way circulation from clean to dirty areas

• Pass boxes to transfer supply containers in and out of facility

• Locker rooms at the clean corridor entrance and the dirty corridor exit

• Showers required to work in an animal room, and again on exiting

• Controlled airflow

Identify the components of a dual-corridor floor plan that help reduce the potential for cross-contamination

Three-corridor floor plan

A modification used in large facilities, where a single clean corridor serves rooms on both sides

Mixed floor plan

Facility design that combines circulation patterns for practicality

Bioexclusion barrier (sterile PPE, may be required to shower before entry)

Prevents entry of microorganisms to protect the animals

Biocontainment barrier

Prevents pathogens from leaving the room, protecting people and animals elsewhere in the facility

• Animal work is usually done in a laminar flow cabinet

• All materials that go into the animal room must be autoclaved and then passed through a portal from the clean corridor

• Waste passed out of facility via a separate route

• Positive air pressure is maintained to avoid airborne contamination

Identify the components used to maintain a bioexclusion barrier

Bioexclusion

Which type of barrier facility maintains positive air pressure to avoid airborne contamination?

Specific-pathogen-free (SPF)

Animals that are guaranteed free of particular pathogens

Modified specific-pathogen-free (SPF)

Requires less strict procedures than that of a bioexclusion barrier, while still requiring some effort to prevent contamination of the animals within

Aim to protect personnel and prevent contamination from organisms or toxins used in laboratories and animal facilities

Identify the purpose of the guidelines listed in the publication Biosafety in Microbiological and Biomedical Laboratories (BMBL)

• PPE for eye and respiratory protection

• Signs outside of containment facility to indicate the hazardous agent being used

• Use of anteroom to put on PPE before entering the animal room

• Special exit procedures such as one-way airlocks and showers

• Materials decontaminated before leaving biocontainment area

Identify the components used to maintain a biocontainment barrier

Anterooms

Used to put on PPE and help segregate infectious items to minimize contamination

Biocontainment

Which type of barrier facility maintains negative air pressure to help contain airborne contaminants?

• Acquiring SPF animals from trusted sources

• Health surveillance monitoring program

• Storage away from waste disposal areas

• Separating soiled cage storage and receiving areas from clean animal housing, procedure rooms, and corridors

• Wearing PPE when working in animal areas, and changing PPE between animal rooms

Identify examples of procedures and precautions that protect the animals from exposure to microorganisms

Temperature and humidity (high levels rec'd for post-op recovery)

Two important variables of the macroenvironment that should be controlled, monitored, and documented daily

Ringtail - tail skin is dry and may blacken due to loss of blood supply

Low relative humidity can cause a condition in rats and mice called

Hygro (i.e hygrometer)

Refers to humidity

Dry-bulb

Refers to the protection of the thermometer bulb from moisture used to measure temperature

Wet-bulb

Used as a measure of humidity

Building management system (BMS)

Computerized system to collect and store temperature and humidity data

• Carbon dioxide

• Ammonia

• Airborne pathogens

• Odors

• Chemical contaminants

• Particulate matter in the room air

Filtered air and adequate air exchanges help reduce the level of

Ammonia

A gaseous byproduct from the bacterial metabolism of urea, a substance found in urine

Irritates the respiratory passages and makes these tissues more vulnerable to infection and disease

Ammonia is heavier than air and becomes concentrated in poorly ventilated rooms or cages. What effect can this have on laboratory animals?

Mycoplasma pulmonis

A pathogenic microorganism that may inhabit the upper respiratory tract of mice and rats, especially when air levels of ammonia are high

10-15 room air changes per hour

What is the acceptable standard for room air changes per hour?

Levels of supply and exhaust flows

What factors determine positive or negative room pressure?

The airflow into the room is greater than the exhaust flow out

Explain the relationship between airflow in a room with positive pressure and the exhaust flow out

• Surgical suites

• Barrier rooms

• Animal rooms

Identify examples of rooms with positive pressure ventilation

To keep contaminants from entering the room

Identify the purpose of a positive pressure room

The air pressure in the room is lower than that of the surrounding areas, and the airflow exhaust is greater than the supply

Explain the relationship between airflow in a room with negative pressure and the exhaust flow out

To keep contaminants from leaving the room

Identify the purpose of a negative pressure room

• Quarantine

• Rooms with infectious agents

• Biohazards

Identify examples of rooms with negative pressure ventilation

Microenvironment refers to the cage

Macroenvironment refers to the room

Identify the difference between a microenvironment and macroenvironment

Static microisolation cages (associated with decreased weight gain in mice)

Cage type with higher temperatures that accumulate more carbon dioxide, ammonia, and humidity than individually ventilated cages

Individual ventilated cage (IVC)

Cage type that controls air quality in animal cages

Laminar airflow systems (cage change cabinets, biosafety cabinets, and animal holding cubicles have these)

Provide a continuous flow of filtered air in a uniform, unidirectional stream

Reduces the air turbulence that can stir up infectious aerosols that pose a risk to personnel

Identify the purpose of laminar airflow systems in cabinets and animal holding cubicles

• Air is drawn through a pre-filter and forced into a plenum (distribution chamber)

• Are moves through HEPA filters and over the work surface

How does a laminar flow cabinet work?

HEPA filter

99.97% effective in removing particulate matter, as small as 0.3 microns

An integral part of a laminar flow cabinet that reduces airborne particles

• Provide HEPA-filtered air to each individual cage

• Provides a cage-level barrier with continuous airflow

• Helps reduce intracage ammonia levels

Identify the benefits of using ventilated cage racks

Animal room lighting, noise, and vibration

Identify variables that can affect the physiology, morphology, and behavior of laboratory animal species

Light intensity and light cycle

The two critical factors pertaining to animal room lighting are

Causes stress and reduced breeding in rodents and birds

How can variations in light cycle negatively affect laboratory animals?